DULOXETIN (CYMBALTA) INDICATIONS
Duloxetin is used for treating depression and generalized anxiety disorder. It is used for managing pain caused by fibromyalgia and diabetic peripheral neuropathy (DPNP). Duloxetin is a serotonin and norepinephrine reuptake inhibitor (SNRI). It works by restoring the balance of certain natural substances in the brain (serotonin and norepinephrine), which helps to improve certain mood problems.
DULOXETIN (CYMBALTA) INSTRUCTIONS
Use Duloxetin as directed by your doctor.
- Take Duloxetin by mouth with or without food. Taking it with food may help to decrease the chance of nausea or stomach upset.
- Swallow Duloxetin whole. Do not break, crush, or chew before swallowing. Do not open the capsule and sprinkle the contents on food or in liquid.
- Take Duloxetin on a regular schedule to get the most benefit from it. Taking Duloxetin at the same time each day will help you remember to take it.
- Continue to take Duloxetin even if you feel well. Do not miss any dose.
- Do not suddenly stop taking Duloxetin without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, diarrhea, dizziness, confusion, headache, increased sweating, nausea, nightmare, ringing in the ears, seizures, trouble sleeping, unusual tiredness, or vomiting. You will be closely monitored when you start Duloxetin and whenever a change in dose is made.
- If you miss a dose of Duloxetin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Duloxetin.
DULOXETIN (CYMBALTA) STORAGE
Store Duloxetin at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Duloxetin out of the reach of children and away from pets.
MORE INFO:
Active Ingredient:
Do NOT use Duloxetin if:
- you are allergic to any ingredient in Duloxetin
- you have uncontrolled narrow-angle glaucoma
- you have liver problems or severe kidney problems, or you are having dialysis
- you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
- you are taking a quinolone antibiotic (eg, ciprofloxacin), a selective serotonin reuptake inhibitor (SSRI) (eg, fluoxetine, fluvoxamine), an SNRI (eg, venlafaxine), thioridazine, or tryptophan.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Duloxetin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
- if you have a history of seizures, heart problems (eg, heart failure, irregular heartbeat), recent heart attack, high blood pressure, kidney problems, diabetes, stomach or bowel problems (eg, slowed emptying), or increased eye pressure (eg, glaucoma)
- if you are dehydrated, have trouble urinating, have low blood sodium levels, or drink alcohol.
Some medicines may interact with Duloxetin. Tell your health care provider if you are taking any other medicines, especially any of the following:
- 5-HT1
- Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
- Cimetidine, medicines for high blood pressure, or quinolone antibiotics (eg, ciprofloxacin) because they may increase the risk of Duloxetin's side effects
- Certain antiarrhythmics (eg, flecainide, propafenone), phenothiazines (eg, chlorpromazine, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Duloxetin.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Duloxetin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Important safety information:
- Duloxetin may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Duloxetin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
- Duloxetin may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Duloxetin; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Do not suddenly stop taking Duloxetin. Some conditions may become worse when the medicine is suddenly stopped or the dose of Duloxetin is decreased. Your dose may need to be slowly lowered to decrease the risk of side effects.
- Children and teenagers who take Duloxetin may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take Duloxetin closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Duloxetin. Your risk may be greater if you take Duloxetin with certain other medicines (eg, MAOIs, SSRIs, "triptans"). Symptoms may include agitation; coma; confusion; excessive sweating; fast or irregular heartbeat; fever; hallucinations; nausea, vomiting, or diarrhea; tremor. Contact your doctor at once if you have any of these symptoms.
- Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Duloxetin. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
- Diabetes patients - Duloxetin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- If your doctor tells you to stop taking Duloxetin, you will need to wait for at least 5 days before beginning to take certain other medicines (eg, MAOIs). Ask your doctor when you should start to take your new medicines after you have stopped taking Duloxetin.
- Lab tests, including blood pressure and liver function, may be performed while you use Duloxetin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Duloxetin with caution in the elderly; they may be more sensitive to its effects, especially low blood sodium levels.
- Caution is advised when using Duloxetin in children; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.
- Duloxetin should be used with extreme caution in children; safety and effectiveness in children have not been confirmed.
- Pregnancy and breast-feeding: Duloxetin may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Duloxetin while you are pregnant. Duloxetin is found in breast milk. Do not breastfeed while taking Duloxetin.
All medicines may cause side effects, but many people have no, or minor, side effects.
Check with your doctor if any of these most common side effects persist or become bothersome:
Constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; loss of appetite; nausea; sore throat; tiredness; trouble sleeping; vomiting; weakness.
Seek medical attention right away if any of these severe side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bizarre behavior; bloody or black, tarry stools; blurred vision; confusion; dark urine; decreased concentration; decreased coordination; excessive sweating; fainting; fast or irregular heartbeat; fever or chills; hallucinations; memory loss; new or worsening aggressiveness, agitation, anxiety, hostility, impulsiveness, irritability, panic attacks, restlessness, or inability to sit still; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent dizziness or headache; severe or persistent nausea, vomiting, or diarrhea; severe or persistent tiredness or weakness; severe or persistent trouble sleeping; stiff muscles; stomach pain; suicidal thoughts or attempts; tremor; trouble urinating or change in the amount of urine produced; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; vomit that looks like coffee grounds; worsening of depression; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.